BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23579949 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01133
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 NOVEMBER 2025. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2210699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER D 42/+3MM (K170452) LOT 2117050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2022. EXPIRATION DATE: 2027-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SHOULDER SURGERY USING A COMPETITOR' S IMPLANTS. ON (B)(6) 2023, THE PATIENT WAS REVISED FOR UNKNOWN REASONS. THE SURGEON REVISED THE STEM, METAPHYSIS, AND LINER TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN RELATED TO SCAPULAR NOTCHING AND THE CAUSE OF THE NOTCHING IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR GLENOSPHERE TO A COMPETITOR GLENOSPHERE AND REVISED THE MEDACTA METAPHYSIS AND LINER TO A MEDACTA METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316969 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2210699 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention